🔍 RecallPedia

Integra Cadence Total Ankle System

Class I - Dangerous
🏥 Medical Devices Recalled: January 20, 2017 Integra LifeSciences Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Model Number, Item Description, and Lot Number: 10207101, Cadence Tibial Tray, Size 1, Right Lots: QJ0231, QJ0231-G, QJ0467, QJ0467-G; 10207102 Cadence Tibial Tray, Size 2, Right Lots: QJ0227, QJ0227-G, QJ0233, QJ0469, QJ0500, QJ0500-G; 10207103 Cadence Tibial Tray, Size 3, Right Lots: QJ0235, QJ0235-1, QJ0235-1-G, QJ0471, QJ0502-G; 10207104 Cadence Tibial Tray, Size 4, Right Lots: QJ0237, QJ02371, QJ0237-1G, QJ0237-G, QJ0473, QJ0504-G; 10207105 Cadence Tibial Tray, Size 5, Right Lots: QJ0239, QJ0239-1-G, QJ0239G, QJ0475; 10207111 Cadence Tibial Tray, Size 1X, Right Lots: QJ0232, QJ0232-G, QJ0468, QJ0499-G; 10207112 Cadence Tibial Tray, Size 2X, Right Lots: QJ0228, QJ0228-G, QJ0234, QJ0234-G, QJ0470, QJ0501-G; 10207113 Cadence Tibial Tray, Size 3X, Right Lots: QJ0236, QJ0236-1, QJ0236-1-1G, QJ0236-1G, QJ0472, QJ0503, QJ0503-G; 10207114 Cadence Tibial Tray, Size 4X, Right Lots: QJ0238, QJ0238G, QJ0474, QJ0505-G; 10207201 Cadence Tibial Tray, Size 1, Left Lots: QJ0240, QJ0240G, QJ0249, QJ0476; 10207202 Cadence Tibial Tray, Size 2, Left Lots: QJ0242, QJ0242-1-G, QJ0242-2-G, QJ0242-G, QJ0478, QJ0478-G, QJ0507-G; 10207203 Cadence Tibial Tray, Size 3, Left Lots: QJ0244, QJ0244G, QJ0253, QJ0480, QJ0480-G, QJ0509-G; 10207204 Cadence Tibial Tray, Size 4, Left Lots: QJ0246, QJ0246G, QJ0255, QJ0482; 10207205 Cadence Tibial Tray, Size 5, Left Lots: QJ0248, QJ0248G, QJ0257, QJ0484; 10207211 Cadence Tibial Tray, Size 1X, Left Lots: QJ0241, QJ0241G, QJ0477, QJ0477-G, QJ0506; 10207212 Cadence Tibial Tray, Size 2X, Left Lots: QJ0243, QJ0243G, QJ0252, QJ0479, QJ0479-G, QJ0508, QJ0508-G; 10207213 Cadence Tibial Tray, Size 3X, Left Lots: QJ0245, QJ0245G, QJ0481, QJ0481-G, QJ0510, QJ0510-G; 10207214 Cadence Tibial Tray, Size 4X, Left Lots: QJ0247, QJ0247-G, QJ0256, QJ0483, QJ0483-G, QJ0511, QJ0511-G
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Integra LifeSciences Corp.
Reason for Recall:
Posterior tibial fractures have been reported.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Integra Cadence Total Ankle System

Product Codes/Lot Numbers:

Model Number, Item Description, and Lot Number: 10207101, Cadence Tibial Tray, Size 1, Right Lots: QJ0231, QJ0231-G, QJ0467, QJ0467-G; 10207102 Cadence Tibial Tray, Size 2, Right Lots: QJ0227, QJ0227-G, QJ0233, QJ0469, QJ0500, QJ0500-G; 10207103 Cadence Tibial Tray, Size 3, Right Lots: QJ0235, QJ0235-1, QJ0235-1-G, QJ0471, QJ0502-G; 10207104 Cadence Tibial Tray, Size 4, Right Lots: QJ0237, QJ02371, QJ0237-1G, QJ0237-G, QJ0473, QJ0504-G; 10207105 Cadence Tibial Tray, Size 5, Right Lots: QJ0239, QJ0239-1-G, QJ0239G, QJ0475; 10207111 Cadence Tibial Tray, Size 1X, Right Lots: QJ0232, QJ0232-G, QJ0468, QJ0499-G; 10207112 Cadence Tibial Tray, Size 2X, Right Lots: QJ0228, QJ0228-G, QJ0234, QJ0234-G, QJ0470, QJ0501-G; 10207113 Cadence Tibial Tray, Size 3X, Right Lots: QJ0236, QJ0236-1, QJ0236-1-1G, QJ0236-1G, QJ0472, QJ0503, QJ0503-G; 10207114 Cadence Tibial Tray, Size 4X, Right Lots: QJ0238, QJ0238G, QJ0474, QJ0505-G; 10207201 Cadence Tibial Tray, Size 1, Left Lots: QJ0240, QJ0240G, QJ0249, QJ0476; 10207202 Cadence Tibial Tray, Size 2, Left Lots: QJ0242, QJ0242-1-G, QJ0242-2-G, QJ0242-G, QJ0478, QJ0478-G, QJ0507-G; 10207203 Cadence Tibial Tray, Size 3, Left Lots: QJ0244, QJ0244G, QJ0253, QJ0480, QJ0480-G, QJ0509-G; 10207204 Cadence Tibial Tray, Size 4, Left Lots: QJ0246, QJ0246G, QJ0255, QJ0482; 10207205 Cadence Tibial Tray, Size 5, Left Lots: QJ0248, QJ0248G, QJ0257, QJ0484; 10207211 Cadence Tibial Tray, Size 1X, Left Lots: QJ0241, QJ0241G, QJ0477, QJ0477-G, QJ0506; 10207212 Cadence Tibial Tray, Size 2X, Left Lots: QJ0243, QJ0243G, QJ0252, QJ0479, QJ0479-G, QJ0508, QJ0508-G; 10207213 Cadence Tibial Tray, Size 3X, Left Lots: QJ0245, QJ0245G, QJ0481, QJ0481-G, QJ0510, QJ0510-G; 10207214 Cadence Tibial Tray, Size 4X, Left Lots: QJ0247, QJ0247-G, QJ0256, QJ0483, QJ0483-G, QJ0511, QJ0511-G

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1192-2017

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Class I - Dangerous

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